Soft Tissue Massage Along With Mobilization Technique on Symptoms and Functional Status of Carpal Tunnel Syndrome

NCT ID: NCT05466162

Last Updated: 2022-07-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-21

Study Completion Date

2022-08-31

Brief Summary

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The objective of this experimental study is to determine the effect of soft tissue massage along with mobilization technique on intensity of pain by visual analog scale and functional status by using Jamar hand-held dynamometer, Pinch Gauge and Boston Scale for carpal tunnel syndrome questionnaire in Carpal tunnel syndrome patients. It is being conducted on patients with Carpal tunnel syndrome at Sindh Institute of Physical Medicine and Rehabilitation, Karachi and Neurological outpatient department of Dr. Ruth K. M. Pfau, Civil Hospital Karachi among Sixty participants with mild and moderate severity of Carpal Tunnel Syndrome will be randomly allocated in two groups after initial screening by a consultant physiatrist according to CTS-6 scale. Written informed consent will be taken from each participant. Group A will be treated with soft tissue massage (Medenci hand massage technique) along with joint (radiocarpal and inter-carpal) and median nerve mobilization slider technique while group B will be treated with joint (radiocarpal and inter-carpal) and median nerve mobilization slider technique only. Participant will be evaluated by visual analog pain scale, Boston scale of carpal tunnel syndrome, dynamometer and -pinch gauge, Center for Epidemiologic Studies Depression Scale and Pain Anxiety Symptoms Scale on day 1 and last treatment session.

Detailed Description

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Conditions

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Carpal Tunnel Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

It is a randomized controlled trial. Total 60 patients will be recruited, 30 in each group that includes There will be one interventional group and one control group. Treatment will be allocated by using a random number sheet generated by SPSS software version 21. Participants are assigned to one of two groups in parallel for the duration of the study.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
The interventions assigned to individual participants will be kept hidden from the outcome assessors in the clinical trial.

Study Groups

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Soft tissue mobilization + joint and nerve Mobilization

Soft tissue massage therapy includes Madenci hand massage technique initiate with 30-second (sec) effleurage, followed by 60- sec friction, 30-sec petrissage, 30-sec shaking, and ends with 30-sec effleurage. It takes totally of 3 min Passive mobilizations of the wrist : radio-carpal joint in flexion and extension, maintained hand in traction. (30 oscillations, 5 sets and 30 secs interval between each step)

Inter-carpal horizontal flexion and extension. (30 oscillations, 5 sets and 30 secs interval between each step)

. Nerve Mobilization treatment( Slider technique) followed by Shoulder will be in depression, abduction on gleno-humeral joint and rotated externally, forearm will be in a supination, elbow flexion and wrist, elbow extension and wrist, thumb, and finger flexion Treatment sessions: 3set, 10 reps, with hold for 10 secs.

Group Type EXPERIMENTAL

Soft tissue mobilization

Intervention Type OTHER

Soft tissue massage therapy includes Madenci hand massage technique initiate with 30-second (sec) effleurage, followed by 60- sec friction, 30-sec petrissage, 30-sec shaking, and ends with 30-sec effleurage. It takes totally of 3 min Passive mobilizations of the wrist : radio-carpal joint in flexion and extension, maintained hand in traction. (30 oscillations, 5 sets and 30 secs interval between each step)

Inter-carpal horizontal flexion and extension. (30 oscillations, 5 sets and 30 secs interval between each step)

. Nerve Mobilization treatment( Slider technique) followed by Shoulder will be in depression, abduction on gleno-humeral joint and rotated externally, forearm will be in a supination, elbow flexion and wrist, elbow extension and wrist, thumb, and finger flexion Treatment sessions: 3set, 10 reps, with hold for 10 secs

Joint and nerve mobilization

Intervention Type OTHER

Passive mobilizations of the wrist : radio-carpal joint in flexion and extension, maintained hand in traction. (30 oscillations, 5 sets and 30 secs interval between each step)

Inter-carpal horizontal flexion and extension. (30 oscillations, 5 sets and 30 secs interval between each step)

Nerve Mobilization treatment( Slider technique) followed by Shoulder will be in depression, abduction on gleno-humeral joint and rotated externally, forearm will be in a supination, elbow flexion and wrist, elbow extension and wrist, thumb, and finger flexion Treatment sessions: 3set, 10 reps, with hold for 10 secs.

joint and nerve mobilizations

Inter-carpal horizontal flexion and extension. (30 oscillations, 5 sets and 30 secs interval between each step)

. Nerve Mobilization treatment( Slider technique) followed by Shoulder will be in depression, abduction on gleno-humeral joint and rotated externally, forearm will be in a supination, elbow flexion and wrist, elbow extension and wrist, thumb, and finger flexion Treatment sessions: 3set, 10 reps, with hold for 10 secs

Group Type ACTIVE_COMPARATOR

Joint and nerve mobilization

Intervention Type OTHER

Passive mobilizations of the wrist : radio-carpal joint in flexion and extension, maintained hand in traction. (30 oscillations, 5 sets and 30 secs interval between each step)

Inter-carpal horizontal flexion and extension. (30 oscillations, 5 sets and 30 secs interval between each step)

Nerve Mobilization treatment( Slider technique) followed by Shoulder will be in depression, abduction on gleno-humeral joint and rotated externally, forearm will be in a supination, elbow flexion and wrist, elbow extension and wrist, thumb, and finger flexion Treatment sessions: 3set, 10 reps, with hold for 10 secs.

Interventions

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Soft tissue mobilization

Soft tissue massage therapy includes Madenci hand massage technique initiate with 30-second (sec) effleurage, followed by 60- sec friction, 30-sec petrissage, 30-sec shaking, and ends with 30-sec effleurage. It takes totally of 3 min Passive mobilizations of the wrist : radio-carpal joint in flexion and extension, maintained hand in traction. (30 oscillations, 5 sets and 30 secs interval between each step)

Inter-carpal horizontal flexion and extension. (30 oscillations, 5 sets and 30 secs interval between each step)

. Nerve Mobilization treatment( Slider technique) followed by Shoulder will be in depression, abduction on gleno-humeral joint and rotated externally, forearm will be in a supination, elbow flexion and wrist, elbow extension and wrist, thumb, and finger flexion Treatment sessions: 3set, 10 reps, with hold for 10 secs

Intervention Type OTHER

Joint and nerve mobilization

Passive mobilizations of the wrist : radio-carpal joint in flexion and extension, maintained hand in traction. (30 oscillations, 5 sets and 30 secs interval between each step)

Inter-carpal horizontal flexion and extension. (30 oscillations, 5 sets and 30 secs interval between each step)

Nerve Mobilization treatment( Slider technique) followed by Shoulder will be in depression, abduction on gleno-humeral joint and rotated externally, forearm will be in a supination, elbow flexion and wrist, elbow extension and wrist, thumb, and finger flexion Treatment sessions: 3set, 10 reps, with hold for 10 secs.

Intervention Type OTHER

Other Intervention Names

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Nerve mobilization( Slider technique) Joint mobilization

Eligibility Criteria

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Inclusion Criteria

* Consultant Physiatrist will be diagnosed patients of carpal tunnel syndrome on electro diagnostic test i.e. Nerve Conduction Studies.
* Mild and moderate severity of Carpal tunnel syndrome.
* Age: 18-50 years
* Both gender patients with unilateral involvement of the hand

Exclusion Criteria

* In electro diagnostic test, either motor or sensory deficit in the ulnar nerve and radial nerve.
* Other Neurological problems ( cervical myelopathy, motor neuron disease like amyotrophic lateral sclerosis
* Neoplasm around the affected arm
* Presence of other musculoskeletal problems of upper quadrant (for example: rheumatoid arthritis or fibromyalgia, cervical radiculopathy)
* Any recent history of trauma of upper extremity on affected side
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dow University of Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Hamna Syed

Hamna Syed

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hamna Syed, DPT

Role: PRINCIPAL_INVESTIGATOR

Dow University of Health Sciences

Dr. Syed Imran Ahmed, MBBS,FCPS

Role: STUDY_DIRECTOR

Sindh Institute of Physical Medicine and Rehabilitation

Dr, Naila Naeem Shahbaz, MBBS,FCPS

Role: STUDY_DIRECTOR

Dr. Ruth K.M. Pfau Civil Hospital, Karachi

Aftab Ahmed Mirza Baig, DPT,MSAPT

Role: STUDY_DIRECTOR

Sindh Institute of Physical Medicine and Rehabilitation

Locations

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Sindh Institute of Physical Medicine and Rehabilitation

Karachi, Sindh, Pakistan

Site Status RECRUITING

Countries

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Pakistan

Central Contacts

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Hamna Syed, DPT

Role: CONTACT

+923043257150

Dr.Syed Imran Ahmed, MBBS,FCPS

Role: CONTACT

03002120661

Facility Contacts

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Hamna Syed, DPT

Role: primary

03043257150

Dr.Syed Imran Ahmed, MBBS,FCPS

Role: backup

03002120661

References

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Huisstede BM, Hoogvliet P, Franke TP, Randsdorp MS, Koes BW. Carpal Tunnel Syndrome: Effectiveness of Physical Therapy and Electrophysical Modalities. An Updated Systematic Review of Randomized Controlled Trials. Arch Phys Med Rehabil. 2018 Aug;99(8):1623-1634.e23. doi: 10.1016/j.apmr.2017.08.482. Epub 2017 Sep 20.

Reference Type BACKGROUND
PMID: 28942118 (View on PubMed)

Klokkari D, Mamais I. Effectiveness of surgical versus conservative treatment for carpal tunnel syndrome: A systematic review, meta-analysis and qualitative analysis. Hong Kong Physiother J. 2018 Dec;38(2):91-114. doi: 10.1142/S1013702518500087. Epub 2018 Jul 2.

Reference Type BACKGROUND
PMID: 30930582 (View on PubMed)

Iftikhar S, Javed MA, Kasuri MN. Frequency of Metabolic Syndrome and Its Components in Patients with Carpal Tunnel Syndrome. J Coll Physicians Surg Pak. 2016 May;26(5):380-3.

Reference Type BACKGROUND
PMID: 27225142 (View on PubMed)

Papanicolaou GD, McCabe SJ, Firrell J. The prevalence and characteristics of nerve compression symptoms in the general population. J Hand Surg Am. 2001 May;26(3):460-6. doi: 10.1053/jhsu.2001.24972.

Reference Type BACKGROUND
PMID: 11418908 (View on PubMed)

de Krom MC, Knipschild PG, Kester AD, Thijs CT, Boekkooi PF, Spaans F. Carpal tunnel syndrome: prevalence in the general population. J Clin Epidemiol. 1992 Apr;45(4):373-6. doi: 10.1016/0895-4356(92)90038-o.

Reference Type BACKGROUND
PMID: 1569433 (View on PubMed)

Nataraj R, Evans PJ, Seitz WH Jr, Li ZM. Effects of carpal tunnel syndrome on reach-to-pinch performance. PLoS One. 2014 Mar 14;9(3):e92063. doi: 10.1371/journal.pone.0092063. eCollection 2014.

Reference Type BACKGROUND
PMID: 24632925 (View on PubMed)

Soon B, Vicenzino B, Schmid AB, Coppieters MW. Facilitatory and inhibitory pain mechanisms are altered in patients with carpal tunnel syndrome. PLoS One. 2017 Aug 30;12(8):e0183252. doi: 10.1371/journal.pone.0183252. eCollection 2017.

Reference Type BACKGROUND
PMID: 28854251 (View on PubMed)

Newington L, Harris EC, Walker-Bone K. Carpal tunnel syndrome and work. Best Pract Res Clin Rheumatol. 2015 Jun;29(3):440-53. doi: 10.1016/j.berh.2015.04.026. Epub 2015 May 27.

Reference Type BACKGROUND
PMID: 26612240 (View on PubMed)

Aboonq MS. Pathophysiology of carpal tunnel syndrome. Neurosciences (Riyadh). 2015 Jan;20(1):4-9.

Reference Type BACKGROUND
PMID: 25630774 (View on PubMed)

Shin YH, Yoon JO, Kim YK, Kim JK. Psychological Status Is Associated With Symptom Severity in Patients With Carpal Tunnel Syndrome. J Hand Surg Am. 2018 May;43(5):484.e1-484.e8. doi: 10.1016/j.jhsa.2017.10.031. Epub 2018 Jan 3.

Reference Type BACKGROUND
PMID: 29305236 (View on PubMed)

Koca I, Boyaci A, Tutoglu A, Ucar M, Kocaturk O. Assessment of the effectiveness of interferential current therapy and TENS in the management of carpal tunnel syndrome: a randomized controlled study. Rheumatol Int. 2014 Dec;34(12):1639-45. doi: 10.1007/s00296-014-3005-3. Epub 2014 Apr 12.

Reference Type BACKGROUND
PMID: 24728028 (View on PubMed)

Eftekharsadat B, Babaei-Ghazani A, Habibzadeh A. The Efficacy of 100 and 300 mg Gabapentin in the Treatment of Carpal Tunnel Syndrome. Iran J Pharm Res. 2015 Fall;14(4):1275-80.

Reference Type BACKGROUND
PMID: 26664397 (View on PubMed)

Geler Kulcu D, Bursali C, Aktas I, Bozkurt Alp S, Unlu Ozkan F, Akpinar P. Kinesiotaping as an alternative treatment method for carpal tunnel syndrome. Turk J Med Sci. 2016 Jun 23;46(4):1042-9. doi: 10.3906/sag-1503-4.

Reference Type BACKGROUND
PMID: 27513402 (View on PubMed)

Chung VC, Wong SY, Kung K, Zee CY, Leung WN, Chong KC, Wong M, Wong C, Griffiths SM. Electroacupuncture and wrist splinting for carpal tunnel syndrome: a randomised trial. Hong Kong Med J. 2017 Jun;23 Suppl 2(3):28-31. No abstract available.

Reference Type BACKGROUND
PMID: 29938668 (View on PubMed)

Khosrawi S, Emadi M, Mahmoodian AE. Effectiveness of splinting and splinting plus local steroid injection in severe carpal tunnel syndrome: A Randomized control clinical trial. Adv Biomed Res. 2016 Feb 8;5:16. doi: 10.4103/2277-9175.175902. eCollection 2016.

Reference Type BACKGROUND
PMID: 26962518 (View on PubMed)

Lewis KJ, Coppieters MW, Ross L, Hughes I, Vicenzino B, Schmid AB. Group education, night splinting and home exercises reduce conversion to surgery for carpal tunnel syndrome: a multicentre randomised trial. J Physiother. 2020 Apr;66(2):97-104. doi: 10.1016/j.jphys.2020.03.007. Epub 2020 Apr 11.

Reference Type BACKGROUND
PMID: 32291222 (View on PubMed)

Lindstrom-Hazel D, Kratt A, Bix L. Interrater reliability of students using hand and pinch dynamometers. Am J Occup Ther. 2009 Mar-Apr;63(2):193-7. doi: 10.5014/ajot.63.2.193.

Reference Type BACKGROUND
PMID: 19432057 (View on PubMed)

Klimek L, Bergmann KC, Biedermann T, Bousquet J, Hellings P, Jung K, Merk H, Olze H, Schlenter W, Stock P, Ring J, Wagenmann M, Wehrmann W, Mosges R, Pfaar O. Visual analogue scales (VAS): Measuring instruments for the documentation of symptoms and therapy monitoring in cases of allergic rhinitis in everyday health care: Position Paper of the German Society of Allergology (AeDA) and the German Society of Allergy and Clinical Immunology (DGAKI), ENT Section, in collaboration with the working group on Clinical Immunology, Allergology and Environmental Medicine of the German Society of Otorhinolaryngology, Head and Neck Surgery (DGHNOKHC). Allergo J Int. 2017;26(1):16-24. doi: 10.1007/s40629-016-0006-7. Epub 2017 Jan 19.

Reference Type BACKGROUND
PMID: 28217433 (View on PubMed)

Madenci E, Altindag O, Koca I, Yilmaz M, Gur A. Reliability and efficacy of the new massage technique on the treatment in the patients with carpal tunnel syndrome. Rheumatol Int. 2012 Oct;32(10):3171-9. doi: 10.1007/s00296-011-2149-7. Epub 2011 Sep 28.

Reference Type BACKGROUND
PMID: 21953301 (View on PubMed)

Dinarvand V, Abdollahi I, Raeissadat SA, Mohseni Bandpei MA, Babaee M, Talimkhani A. The Effect of Scaphoid and Hamate Mobilization on Treatment of Patients with Carpal Tunnel Syndrome. Anesth Pain Med. 2017 Oct 23;7(5):e14621. doi: 10.5812/aapm.14621. eCollection 2017 Oct.

Reference Type BACKGROUND
PMID: 29696114 (View on PubMed)

Wolny T, Linek P. Is manual therapy based on neurodynamic techniques effective in the treatment of carpal tunnel syndrome? A randomized controlled trial. Clin Rehabil. 2019 Mar;33(3):408-417. doi: 10.1177/0269215518805213. Epub 2018 Oct 11.

Reference Type BACKGROUND
PMID: 30306805 (View on PubMed)

Wolny T, Linek P. Neurodynamic Techniques Versus "Sham" Therapy in the Treatment of Carpal Tunnel Syndrome: A Randomized Placebo-Controlled Trial. Arch Phys Med Rehabil. 2018 May;99(5):843-854. doi: 10.1016/j.apmr.2017.12.005. Epub 2018 Jan 4.

Reference Type BACKGROUND
PMID: 29307812 (View on PubMed)

De-la-Llave-Rincon AI, Ortega-Santiago R, Ambite-Quesada S, Gil-Crujera A, Puentedura EJ, Valenza MC, Fernandez-de-las-Penas C. Response of pain intensity to soft tissue mobilization and neurodynamic technique: a series of 18 patients with chronic carpal tunnel syndrome. J Manipulative Physiol Ther. 2012 Jul;35(6):420-7. doi: 10.1016/j.jmpt.2012.06.002. Epub 2012 Jul 31.

Reference Type BACKGROUND
PMID: 22858234 (View on PubMed)

Fernandez-de-Las-Penas C, Cleland J, Palacios-Cena M, Fuensalida-Novo S, Pareja JA, Alonso-Blanco C. The Effectiveness of Manual Therapy Versus Surgery on Self-reported Function, Cervical Range of Motion, and Pinch Grip Force in Carpal Tunnel Syndrome: A Randomized Clinical Trial. J Orthop Sports Phys Ther. 2017 Mar;47(3):151-161. doi: 10.2519/jospt.2017.7090. Epub 2017 Feb 3.

Reference Type BACKGROUND
PMID: 28158963 (View on PubMed)

Other Identifiers

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HamnaS

Identifier Type: -

Identifier Source: org_study_id

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